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Handicare
HANDICARE USA, INC. · Model 329190 · UDI-DI 00810045511207
10
510(k) clearances
15,789
Adverse events (432 deaths)
143
Recalls
208
Facilities
Description
C800 lbs. Power Traverse
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-25 | ARJOHUNTLEIGH POLSKA Sp. z.o.o. | The side support of the shower trolley may open unintentionally when the handles are not fully locked and additional force is applied during patient handling. If the side support i |
| 2026-09-14 | Baxter Healthcare Corporation | Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift strap lowers more quic |
| 2026-03-10 | ARJOHUNTLEIGH POLSKA Sp. z.o.o. | An internal component of the actuators in a certain production batch may not meet the required mechanical strength. This could result, in the worst case scenario, in a sudden loss |
| 2025-12-18 | Community Products, LLC | Potential for fraying on the body support strap. |
| 2025-12-18 | Community Products, LLC | Potential for fraying on the body support strap. |
| 2025-12-18 | Community Products, LLC | Potential for fraying on the body support strap. |
| 2025-11-17 | ETAC A/S | A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it b |
| 2025-11-17 | ETAC A/S | A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it b |
| 2025-11-17 | ETAC A/S | A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it b |
| 2025-11-17 | ETAC A/S | A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it b |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.